Catalog Number

2058SS

Brand Name

Stratis

Version/Model Number

2058SS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 11, 2019

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K041749

Product Code

KMF

Product Code Name

Bandage, liquid

Public Device Record Key

0a229784-7703-4e9d-8ae7-979951c309f0

Public Version Date

April 02, 2020

Public Version Number

3

DI Record Publish Date

August 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-